Procedural cannula and support system for surgical procedures

ABSTRACT

A system for performing minimally invasive medical procedures includes an elongate support advanceable into a body cavity. The elongate support supports a frame that carries a pair of tool cannulas, each of which has a lumen for receiving a tool useable to perform a procedure in the body cavity. The frame is expandable to orient the tool cannulas such that they allow the tools to be used in concert to carry out a procedure at a common location in the body cavity.

RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.11/789,318, filed Apr. 24, 2007, now U.S. Pat. No. 7,883,156, whichclaims the benefit of U.S. Provisional Application No. 60/794,563, filedApr. 24, 2006, U.S. Provisional Application No. 60/801,113, filed May17, 2006, U.S. Provisional Application No. 60/801,034, May 17, 2006, andU.S. Provisional Application No. 60/819,235, filed Jul. 7, 2006.

FIELD OF THE INVENTION

The present invention relates to the field of devices and procedures foruse in performing surgery in the peritoneal cavity using access througha natural orifice.

BACKGROUND OF THE INVENTION

Surgery in the abdominal cavity is typically performed using opensurgical techniques or laparoscopic procedures. Each of these proceduresrequires incisions through the skin and underlying muscle and peritonealtissue, and thus results in the potential for post-surgical scarringand/or hernias.

Systems and techniques in which access to the abdominal cavity is gainedthrough a natural orifice are advantageous in that incisions through theskin and underlying muscle and peritoneal tissue may be avoided. Use ofsuch systems can provide access to the peritoneal cavity using an accessdevice inserted into the esophagus, stomach or intestine (via, forexample, the mouth or rectum). Instruments are then advanced through theaccess device into the peritoneal cavity via an incision in the wall ofthe esophagus, stomach or intestine. Other forms of natural orificeaccess, such as vaginal access, may similarly be used.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an access cannula anchored in anincision in a stomach for use in a natural orifice procedure.

FIG. 2A is a schematic side view showing the interior of an abdominalcavity, and further showing use of a first embodiment of a proceduralcannula and support system.

FIG. 2B is a schematic top view (anterior view) showing the interior ofan abdominal cavity and further illustrating use of the proceduralcannula and support system of FIG. 2A.

FIG. 3 is a perspective view showing an alternative procedural cannulaand support system.

FIG. 4 is a perspective view of the spine of the system of FIG. 3.

FIG. 5A is a perspective view illustrating two of the spine elements ofthe spine of FIG. 4.

FIG. 5B is a perspective view of an alternative spine element for use inthe system of FIG. 3.

FIG. 6 is a perspective view showing the distal ends of the toolcannulas and linkage of the system of FIG. 3.

FIG. 7 is a cross-section view taken along the plane designated 7-7 inFIG. 6.

FIGS. 8A and 8B are a top perspective view and a bottom perspectiveview, respectively, of a distal end of the system of FIG. 3 using anadditional tool cannula.

FIGS. 9 and 10 are perspective views of the system of FIG. 3 extendingfrom an access cannula and including a retractor extending from alongitudinal tool cannula.

FIG. 11A is a top perspective view showing an alternative linkageassembly in combination with a spine, procedural cannulas, and a centralretractor.

FIGS. 11B and 11C are a top plan view and a side elevation view of thelinkage assembly of FIG. 11A. In FIG. 11C, the center retractor is shownin a downwardly deflected position, and phantom lines are shown toillustrate the retractor in an upwardly deflected position.

FIG. 11D is a top plan view of the linkage assembly of FIG. 11A in thestreamlined position.

FIG. 11E is a perspective view similar to FIG. 11E illustratingexemplary movement patterns for the tool cannulas and associated tools.

FIG. 12A is a perspective view of one embodiment of a user interface forthe system of FIG. 3.

FIG. 12B is a perspective view of an alternative user interface for thesystem of FIG. 3.

FIGS. 13 and 14 are a perspective view and a cross-sectional side viewof a gimbal assembly.

FIGS. 15A and 15B are perspective views of the gimbal assembly of FIG.13 showing two exemplary locking mechanisms.

FIGS. 16A and 16B are perspective views of an alternative gimbal system.

FIG. 17 is a perspective view of a third embodiment of a proceduralcannula and support system.

FIG. 18 is a detailed perspective view of the proximal end of the systemof FIG. 17.

FIG. 19 shows the gimbal system of the FIG. 17 embodiment.

FIG. 20 is an exploded view of the gimbal system of FIG. 19.

FIG. 21 is a plan view of the distal surface of the ball of the gimbalsystem of FIG. 19.

FIG. 22 is a plan view of the proximal surface of the ball of FIG. 21,with the cap removed and shown in perspective view.

FIG. 23 is a top view similar to FIG. 2B showing the system of FIGS. 9and 10 in use for surgery on a liver.

FIG. 24 schematically illustrates an abdominal cavity and shows analternative support system mounted to the interior wall of the abdominalcavity.

DETAILED DESCRIPTION OF THE DRAWINGS

Applicant's prior Provisional Application No. U.S. application Ser. No.11/528,009, TRANSGASTRIC SURGICAL DEVICES AND PROCEDURES, Filed Sep. 27,2006 describes various embodiments of surgical access cannulas for usein gaining access to the peritoneal cavity of a patient via a naturalorifice. When used for transoral procedures, the distal end of an accesscannula 10 (FIG. 1) is advanced orally through the esophagus and intothe stomach or intestine. Instruments are passed through the cannula andare used to form an incision in the stomach or intestinal wall, givingaccess to the peritoneal cavity. The access cannula 10 is anchored inthe incision using expandable anchors 12 a, 12 b positioned against theinner and outer surfaces of the stomach wall. Insufflation gas may beintroduced into the peritoneal cavity via the access cannula to createworking space within the cavity. The access cannula may include valvesor seals that allow for sealed access through the incision, permittingsterile passage of instruments into the peritoneal cavity without lossof insufflation pressure. The access cannula 10 may be a flexible tubeformed of polymeric material (e.g. polyurethane) having an embeddedbraid. In other embodiments, a more rigid access cannula may be used.The '009 application, which is incorporated herein by reference,describes various additional components of access cannula systems,including anchoring features, elements for forming incisions in aninterior body wall such as the stomach, and closure devices.

This application describes a procedural cannula and support systemideally used in combination with an access cannula that has been used togain access to the peritoneal cavity. For example, once access cannula10 has been passed through the oral cavity and stomach and securedwithin a stomach wall incision using anchors 12 a, 12 b, a proceduralcannula and support system of the type described herein is passedthrough the access cannula and into the peritoneal cavity.

For certain procedures, it would be advantageous to allow the surgeon toperform a natural orifice surgical procedure in a manner that allowshim/her to approach the surgical target within the peritoneal cavityfrom the same direction from which s/he would typically approach thatsame structure using a laparoscopic or open surgical procedure. Forexample, if a particular procedure utilizes an anterior approach to thetreatment site when carried out using laparoscopic or surgicaltechniques, it would also be desirable to allow the surgeon to approachthe treatment site from an anterior perspective even when using anatural orifice technique. The system illustrated in the attacheddrawings allows these same approaches to be used using natural orificeaccess, thus allowing a surgeon to easily and intuitively transitionbetween natural orifice surgical procedures and open or laparoscopicprocedures.

In general, the disclosed embodiments include at least one procedural ortool cannula through which instruments are passed to the operative site.A support system provides rigid support for the procedural cannula(s)within the body.

Referring to FIGS. 2A and 2B, one embodiment of a natural orificesurgical system includes an instrument system 22 and a support system24. These figures schematically illustrate the peritoneal cavity of apatient with the support system and instrument system extending into thecavity from an incision (not shown) through the stomach wall. In use,the support system 24 forms a sort of scaffold within the body tosupport the instrument system 22 in a location that allows the surgeonto advance the instruments of the instrument system using a desiredapproach. Thus, for example, if performing a procedure that typicallyuses an anterior approach when carried out surgically orlaparoscopically, the user might position the support system 24 adjacentthe abdominal wall W as shown in FIG. 2A.

Support system 24 includes an elongate shaft or spine 26 that extendsfrom an incision in a body organ such as the stomach S or other holloworgan (e.g. intestine, vagina) from which natural orifice access hasbeen gained as described above. In a preferred embodiment, shaft 26 isdisposed within an access cannula 10 which may be of the type shown inFIG. 1. Shaft 26 is preferably one capable of being sufficientlyflexible for passage through the natural orifice and body organ, and formanipulation within the peritoneal space, but also capable of beingplaced in a self-supporting rigid state once positioned at a desiredlocation. In one embodiment, shaft 26 is a shaft formed of a pluralityof spine elements 28 having tensioning cables that may be placed undertension to stiffen the shaft 26. As will be discussed in greater detailbelow, the spine elements are shaped such that the shaft 26 will assumea shape predetermined to give the curvature needed to position the shaft26 at the desired location. Shaft 26 may include a lumen (not shown) orother features for supporting an endoscope (not shown) oriented towardsthe treatment site.

Instrument system 22 includes one or more procedural cannulas 30 a, 30b, each having an opening 152 at or near its distal end. Cannulas 30 a,30 b may include a curved distal portion as shown, and may additionallyor alternatively be deflectable in predetermined directions usingpullwires, mandrels, or other deflection mechanisms, including thoseknown in the art for deflecting catheters, introducers and guidewires.

Instruments 32 (e.g. forceps, endoscopes, suture devices, staplers) areextendable through the procedural cannulas 30 a, 30 b and into positionat the target site in the peritoneal cavity. As best shown in FIG. 2B,two procedural cannulas are useful in that they allow for thesimultaneous use of two instruments 32. The procedural cannulas 30 a, 30b may be passed into the peritoneal cavity via the same access cannula10 (FIG. 1) through which the support shaft 26 extends, or they may bepassed through one or more separately placed access cannulas 10, or, asdescribed in detail in connection with FIG. 3, they may be passedthrough a lumen in the shaft 26.

A coupling 34 couples the instrument system 22 and support system 24.The coupling 24 may by any type of device that couples the proceduralcannulas 30 a, 30 b to the shaft 28. In the FIG. 2A-2B embodiment, thecoupling takes the form of a linkage 36 that allows the cannulas to besuspended from the shaft 26 and also provides the additional benefit ofmaintaining the orientation of the cannulas 30 a, 30 b relative to oneanother. The linkage 36, which is most visible in FIG. 2B, includes afirst mount 38 on the shaft 26, and second mounts 40 a, 40 b on theprocedural cannulas 30 a, 30 b. Linkage bars 42 a, 42 b are pivotallycoupled to the mount 38 and the mounts 40 a, 40 b. Second linkage bars44 a, 44 b are pivotally coupled to, the mounts 40 a, 40 b and a pivotpoint 46. As can be seen in FIGS. 2A and 2B, the support system 24positions the procedural cannulas 30 a, 30 b so that access to thetreatment site can be gained using an approach that is familiar to thepractitioner, despite the fact that the instruments are inserted intothe body using a drastically different approach. Deflection features ofthe cannulas 30 a, 30 b allow those cannulas to be manipulated so as toposition the instruments 32 where they are needed, without requiringthat the instruments include specialized features for steering anddeflection. The linkage 36 maintains the relative orientation of thecannulas 30 a, 30 b towards the treatment site.

FIG. 3 shows a second embodiment of a natural orifice surgical system100. System 100 includes a locking spine 102 and a pair of tool cannulas104. The system 100 is similar to the embodiment of FIGS. 2A and 2B, butdiffers in that the tool cannulas 104 pass through a lumen 105 in theshaft of the locking spine 102 of the support system, allowing for amore streamlined system that occupies a reduced amount of space. Anendoscope 107 also extends through the spine 102, allowing the user toobserve the procedure being carried out at the distal end of the system.Instruments 32 extend from the tool cannulas to the operative sites.Instruments 32 may include forceps, retractors or any other instrumentsneeded to carry out the desired procedure within the peritoneum.

The locking spine 102 is preferably passed into the body through anaccess cannula 10 as described in connection with FIG. 1 and as shown inFIGS. 9 and 10.

Spine 102 is preferably one capable of being sufficiently flexible formanipulation within the peritoneal space, but also capable of beingplaced in a self-supporting rigid state once positioned at a desiredlocation. In one embodiment, spine 102 is a shaft formed of a pluralityof spine elements having tensioning cables that may be placed undertension to stiffen the shaft. The spine elements are shaped such thatthe spine will assume a shape predetermined to give the curvature neededto position the distal end of the spine at the desired location andoriented towards the treatment site.

A detailed view of the locking spine 102 is shown in FIG. 4. Referringto FIG. 4, locking spine 102 is formed of a plurality of spine segments106 a, 106 b threaded over a pair of cables (not shown in FIG. 4) toform a flexible shaft. Each cable is coupled to a locking handle 108that is moveable to the locked position shown in FIG. 4 to apply tensionto the cables and to thereby rigidize the spine 102. To release thespine to a flexible state, the handles are moved in the direction ofarrows A.

A plurality of the spine segments 106 a are cylindrical segments havingend faces that are perpendicular to the axis of the cylindricalsegments. When a plurality of these cylindrical segments 106 a is strungover the cables, they form a relatively straight spine section 110 whenthe handles 108 are locked. Others of the spine segments 106 b haveangular end faces and are assembled such that the chosen combination ofangled segments 106 b will give the distal portion 112 of the spine 102a predetermined bend configuration when the spine 102 is locked as shownin FIG. 4.

FIG. 5A is a perspective view showing a pair of angled spine segments106 b assembled together. Each spine segment includes a central throughhole 114 and a plurality of side through holes 116 surrounding thecentral through hole 114. Similar hole patterns may also be included inthe cylindrical segments 106 a that form the straight section of thespine. A variety of angled spine segments with end faces of differentangles make up the curved distal portion of the spine. A group of spinesegments with a predetermined combination of angles are selected toproduce an overall shape for the spine that will support the associatedtools in an optimal position for the procedure to be carried out withinthe body. In the FIG. 4 embodiment, spine segments are combined tocreate a multi-dimensional bend as shown.

The spine segments 106 a, 106 b etc. are “strung” onto cables 118 bypassing each of the cables through one of the side through holes 116 ineach of the spine segments. The side hole that is to receive the cable118 for a particular spine segment 106 b is selected based on theorientation in which the angled face of that segment must be placed togive the spine 102 the correct curve at that particular location on thespine 102. Thus, manufacturing instructions might list out a sequence ofangled segments, giving for each segment the face angle that is to beused, as well as a designation of which side holes 116 are to receiveeach cable for that particular segment. An exemplary entry on the listmight read “segment #10, angle 15°, cable #1 through hole A, cable #2through hole D”.

The central through holes 114 of the spine segments 106 a, 106 b alignto form the lumen 105 (FIG. 4) of the spine 102.

FIG. 5B shows an alternative spine segment 106 c having a concave endface 103 a and a concave end face 103 b, each of which comes together ina nesting relationship with adjacently placed spine segments. Slots 113may be provided the concave face 103 a for receiving correspondingmating ribs (not shown) on the convex face, allowing the segments to“key” together when assembled to minimize rotational movement ofsegments relative to one another.

In the FIG. 5B embodiment, the central through hole 114 c includes aplurality of lobes 115 a, 115 b, 115 c each sized and positioned suchthat one or more instruments passed through the through hole 114 c canseat in a corresponding one of the lobes. This helps to maintain theinstruments in a stable position within the elongate lumen of the spineformed by the assembly of the segments 106 c. In this embodiment, theholes 116 c through which the cables (not shown) are threaded arepositioned in pairs as shown, although alternate patterns will beequally suitable.

FIG. 6 is a perspective view of the distal end of the system 100 of FIG.3, showing the distal ends of the tool cannulas 104. As with the firstembodiment, the system 100 includes features that work in combinationwith the spine 102 to support and orient the tool cannulas 104 asappropriate for a given procedure. A linkage 120 is pivotally connectedto the cannulas 104 at pivot points 122 and couples the cannulas 104 tothe supporting spine 102. Linkage 120 also provides structural supportfor the distal portions of the tool cannulas 104 and maintains therelative orientation of the cannulas 104. As with the first embodimentand as shown in FIG. 3, the linkage 120 is attached to a pivot mount 124on the distal portion of the locking spine 102. Another of the pivotmounts 125 is coupled to a pull wire 127 that extends proximally throughspine 102 to a location outside the body. In an alternative embodimentshown in FIGS. 8A and 8B, pivot mount 125 may be coupled to the distalportion of a third longitudinal tool cannula 104 a extendinglongitudinally from the spine 102, or to a similarly positioned toolshaft. As another alternative, either or both of the pivot mounts 124,125 may extend into free space as shown in FIGS. 9 and 10 instead ofbeing attached to the cannula 104 a and/or spine 102.

The linkage 120 is positionable in a collapsed streamlined position inwhich tool cannulas 104 are near the longitudinal axis of the spine 102for passage through the access cannula 10. Dashed lines in FIG. 6 showthe arrangement of the linkage 120 and pivot mounts 122 when in thecollapsed position. When in the streamlined position, the pivot mounts122 are positioned side by side, thus orienting the tool cannulas 104adjacent to one another. When in the deployed position, the pivot mountsare positioned approximately 3-7 inches apart, and more preferablyapproximately 4-6 inches apart.

Opening the linkage positions the cannulas 104 as shown in FIGS. 3, 6and 8A-10 and thus points the instruments 32 positioned in the cannulas104 generally towards an operative site. The linkage 120 of FIG. 6 maybe deployed to the open position by withdrawing pullwire 127, whereasthe FIGS. 8A, 8B embodiment can be deployed by advancing the distal endof the longitudinal tool cannula 104 a in a distal direction to move thelinkage 102 out of the access cannula and/or to deploy the linkage tothe expanded position. In other embodiments, one or more of the pivotpoints 122, 124, 125 may be spring loaded to facilitate expansion of thelinkage 120. Any combination of these deployment mechanisms, or othersnot specifically mentioned, may instead be used to deploy the linkage120 in the peritoneal cavity.

In another alternative shown in FIGS. 11A-11C, linkage 120 a includes apair of members 130. Each member 130 is attached by a corresponding oneof the tool cannulas 104 by a first hinge 132 and to a central retractor104 b (or, alternatively, to a longitudinal tool cannula like cannula104 a of FIG. 8A) by a second hinge 134. Hinges 132 may be mounted tocorresponding collars 136 on the tool cannulas 104, and hinge 134 may beon a similar collar 138 (FIG. 11B) on retractor 104 b. When linkage 120a is in the collapsed position, members 130 extend in a distal directionas shown in FIG. 11D. To deploy the linkage 120 a, central retractor 104b is withdrawn proximally, causing the members 130 to pivot at hinges132, 134.

Referring to FIG. 11C, central retractor 104 b includes a proximalsection 140 and a distal section 142. Proximal section 140 is formed ofa number of segments 144 strung onto one or more cables, with shortersegments 146 and an instrument tip 147 on the distal section 142. Cableswithin the retractor 104 b are arranged such that the retractor becomesrigid when the cables are tensioned, and such that distal section 142will deflect when the balance of tension within the cables is alteredusing controls outside the body. For example, retractor 104 b may bedeflectable towards and away from the body tissue as shown in FIG. 11Cto allow tissue to be lifted by the retractor so the tissue may be actedupon by an instrument carried by one of the tool cannulas 104.Additional pull cables (not shown) are operable to open and close thejaws of the retractor tip 147.

In the disclosed embodiments, each tool cannula 104 preferably has apre-shaped curve in its distal region. The curve orients the cannula 104such that when the linkage is opened, instruments 32 (FIGS. 10A, 10B)passed through the central lumens 126 of the cannulas 104 can access acommon treatment site. The preformed shape may be set using any of anumber of methods. For example, the shaped region may have a segmentedconstruction similar to the segmented spine 102, with the individualsegments shaped to give the tool cannulas a shape that will orient thecannulas as shown in FIGS. 3, 9 and 10 when the cables running throughthe segments are tensioned. With this design, the entire length of thecannula may be segmented, or the distal portion may be formed of polymertubing to allow flexibility. Alternatively, cannulas 104 can be made ofpre-curved tubing having rigidity sufficient to prevent buckling duringuse. Reinforcing braid made of stainless steel or other materials may beformed into the walls of the tubing in the rigid section of the cannulas104.

As with the FIG. 2A-2B embodiment, the distal end of each tool cannula104 further includes a region that is deflectable in multiple directionsto allow positioning and manipulation of the operative ends of theinstruments. This avoids the need for sophisticated steerable surgicalinstruments. Instead, instruments 32 (FIG. 10) having flexible shaftsare positioned in the tool cannulas 104, and steering of the instrumentsis achieved by deflecting the tool cannulas 104. Because the tools 32are flexible, it may be necessary to “stiffen” the shaft of the tool 32to allow the tool to be successfully used. A slideable stiffeningcannula 33 (FIG. 10) may be advanced from within the tool cannula 104over a portion of the shaft of the tool 32 to effectively stiffen thetool's shaft during the procedure, thus allowing the tool to be pressedinto contact with body tissue without buckling. Other internalstructures such as stiffening mandrels, reinforcing collars or braids,may instead be used for this purpose.

In a preferred embodiment, deflection of the tool cannulas 104 isperformed using a pullwire system. Referring to FIG. 7, pullwires 128extend through corresponding pullwire lumens 130, preferably spaced atintervals of 90°. The distal ends of the pullwires are anchored in thedistal sections of the cannula 104 such that the distal section of thecannula can be made to deflect in a desired direction by pulling on thedesired combination of pullwires. FIG. 11E illustrates in dashed linesV1 a conical volumes defined by an exemplary movement pattern for thetool cannula 104, and the corresponding volume V2 defined by the tool 32within the cannula 104.

Actuation of the pullwires is achieved using features that during useare positioned outside the body. A deflection system is provided thatallows the user to intuitively actuate the pullwires for a particularone of the tool cannulas 104 by manipulating the handle 152 of theinstrument 32 that resides within that tool cannula. For example, if theuser wishes to have the distal end of a tool move in a downwarddirection, s/he will intuitively raise the handle 152 of that tool tocause the corresponding tool cannula to deflect downwardly, thus movingthe tool to the desired position.

Referring to FIG. 3, the proximal ends of the pullwires 128 extend fromthe proximal ends of the cannulas 104 and feed into a correspondingdeflection system, which in the illustrated embodiments is a controlgimbal 148.

The gimbal 148 may be mounted to a work stand 150 as shown in FIG. 12A.In use the work stand 150 may be set on top of the patient's torso ormounted to supports coupled to one or both side-rails of the surgicaltable, or carried on a cart. In either case, the work stand 150 ispositioned to give the surgeon convenient and intuitive access to thehandles 152 while s/he observes the procedure on an endoscopic display(not shown). As shown in FIG. 12B, use of the system may be facilitatedby providing a “cockpit” for the user, coupling an endoscopic display154 to the work stand 150 that supports the control gimbals 148, as wellas the proximal controls for the endoscope 107, and other ports 111 forpassing instruments through the access cannula to the peritoneal space.

The work stand 150 is proportioned to allow the surgeon to position hisor herself in a comfortable position with his/her hands on the handles153 of the tools 32. The work stand 150 preferably positions the toolhandles 153 approximately 10-15 inches apart.

A preferred control gimbal 148 is shown in FIG. 13. It includes a base168 mounted to the work stand (not shown in FIG. 7) and having a tubularchannel 170. A c-shaped mount 172 is connected to the base 168 andincludes a through hole 174 continuous with the lumen of the tubular endpiece 170. In a slight modification, the hole 174 might be accompaniedby four separate through holes 174 a-d might be used for receiving pullwires as in the FIG. 19 embodiment. A ring 176 is pivotally mounted tothe mount 172 at pivot bearings 178. A semi-spherical ball 180 ispivotally mounted within the ring at pivots 182. Four pull-wire ports184 extend from the interior of the ball 180 to its outer surface.

Instrument port 186 includes side channels 190 having distal openings192 and proximal openings 194. The four pullwires 128 from the toolcannulas 104 extend through the tubular end piece 170 and each passesthrough hole 174, through the hollow interior of the ball 180, and outcorresponding ones of the pull-wire ports 184 in the ball. The pullwiresfurther extend into the instrument port side channels 190 and aresecured there by anchors 196.

Instrument port 186 has a lumen 188 extending proximally from thespherical ball 180. The shaft 152 of an instrument 32 (see FIG. 12A, notshown in FIGS. 13-14) extends through the lumen 188 and the ball 180,through hole 174 in the c-shaped mount 172, and via tube 170 and thework stand 150 (FIG. 12A), into the corresponding tool cannula 104. Theoperative end of the instrument 32 extends from the distal end of thetool cannula 104.

When it becomes necessary for the surgeon to change the orientation ofthe distal end of an instrument 32, s/he need only intuitively move thehandle 152 of that instrument and the distal portion of the instrumentwill deflect accordingly as a result of the action of the gimbal on thepullwires of the tool cannula. Vertical movement of the handle 152 willcause the ball 180 to rotate relative to pivots 182, thus applyingtension to the upper or lower pullwire 128 to cause upward or downwarddeflection of the tool cannula 104 (and thus the distal end of theinstrument 32). Lateral movement of the handle 152 will cause the ball180 and ring 176 to rotate about pivots 178 and to therefore tension oneof the side pullwires to change the lateral bend of the tool cannula104. The control gimbal allows combinations of vertical and lateraldeflection, giving 360° deflection as shown in FIG. 11E. Thus user mayadditionally advance/retract the tool 32 longitudinally within the toolcannula 104, and/or axially rotate the tool 32 relative to the toolcannula when required.

The control gimbal 148 includes a locking mechanism that allows aninstrument orientation to be temporarily fixed until further deflectionis needed. This feature allows a user to fix a trajectory for multipleinstruments that are to be sequentially used at a particular location.For example, once the orientation of a tool cannula 104 is set, acertain step in the procedure may be performed using a first instrumentpassed through that cannula. When a subsequent step requiring adifferent instrument is to be performed, the instruments are exchangedwithout moving the tool cannula 104. This allows the second instrumentto be advanced to the exact location at which it is needed withoutadditional steering.

One exemplary locking mechanism includes a pair of locking screws 198that are tightened as shown by arrows in FIG. 15A to lock the C-mount172 to the ring 176 and to lock the ring 176 and the ball 180.Alternatively, as shown in FIG. 15B, a simple pneumatic shaft lock 200could be employed on each of the gimbal's pivot axes. A solenoid orsimilar device might be used in place of the pneumatic lock 200.

An alternate gimbal arrangement is shown in FIGS. 16A and 16B. As shown,a cone shaped instrument port 202 is mounted to the proximal end of eachcannula, and includes a diaphragm seal 204 having a slit 206 sealablearound an instrument shaft 208 passed into the instrument port 202. InFIGS. 16A and 16B only the handle of instrument shall 208 is shown topermit easier viewing of the surrounding features.

A gimbal 210 includes a collar 212 mounted on the instrument port 202and four wings 214 radiating from the collar 212. Each pullwire 128 iscoupled to one of the wings 214. Struts 216 extend proximally from thewings 214 and are joined to a sleeve 218 through which a portion of theinstrument shaft 208 extends. Collar 212 is moveable relative to theinstrument port 202, and in particular collar 212 is rotatable about itscentral axis, and pivotable in multiple directions. Movement of thecollar 212 places one or more of the pullwires 128 under tension andresults in deflection of the cannula 104. Since the instrument shaft 208is coupled to the collar 212 by struts 216, a user can manipulate theinstrument shall 208 handle in an intuitive manner similar to a joystickto allow the user to steer the distal end of the cannula 104 in thedesired direction.

FIG. 17 illustrates an alternative natural orifice surgical system 300.System 300 includes features that are largely similar to those describedelsewhere. For example, the system 300 uses the linkage 120 a of FIG.11A, and a gimbal system similar to that described in connection withFIG. 13. The system 300 differs from the earlier embodiments in that itallows a user to adjust the sensitivity of the gimbals. In other words,the gimbal can be fine tuned such that the amount of deflection of thetool cannulas corresponds directly to the amount by which the user movesthe tool handles 152 within the gimbal system, or the amount ofdeflection can be greater than or less than the corresponding movementof the tool handles.

Referring to FIG. 19, many of the features of the gimbal 302 are similarto those of gimbal 148 of FIGS. 12 and 13. These similar featuresinclude base 168, which is coupled to frame 304. Four through-holes 174a-d (three of which are visible in FIG. 19), one for each pull wire,extend from c-shaped mount 172 through base 168. The pullwires feed intothe through-holes 174 a-d from cable housings 175 that pass through theframe 304. The more distal segments of the pullwires extend from thefrom the frame 304 into the tool cannulas 104 extending distally fromthe frame 304.

A ring 176 is pivotally mounted to mount 172 at pivots 178, andsemi-spherical ball 180 is pivotally mounted within the ring 176 atpivots 182.

The gimbal 302 of FIG. 19 differs from the gimbal 148 of FIGS. 12-13 inits inclusion of a microadjustment assembly 306. As with the priorgimbal arrangements, the four pullwires of one of the tool cannulasterminate in the gimbal at 90 degree quadrants. Motion of the instrumentshaft 152 (FIG. 17) alters the tension on the various pullwires, whichcauses deflection of the tool cannula tip and corresponding movement ofthe tool within the tool cannula. The effect lever arm of each pull wireis altered in the FIG. 19 embodiment by moving the point of terminationof each pull wire towards or away from the gimbal's center of rotation.Moving the pullwire terminations away from the center of rotation causesmovement of the tool cannula 104 to be amplified relative to themovement of the tool handle 152, whereas moving the pullwireterminations towards the center of rotation decreases the amplification.

Ball 180 includes a distal surface 314 as shown in FIG. 21A, and aplanar proximal surface 316 as shown in FIG. 20. Four radial slots 318a-d extend through between the surfaces 314, 316. Referring to FIG. 20,four sliding terminal plates 308 a-d, each including a pullwire terminal310 a-d and a proximally-extending follower pin 312 a-d, are positionedin contact with the planar proximal surface 316. A peg 317 on the distalside of each terminal plate is received in the corresponding one of theslots 318 a-d.

Each pullwire used to deflect the tool cannula extends through one ofthe slots 318 a-d and is anchored within a terminal 310 a-d of one ofthe four sliding terminals 308 a-d. FIG. 21A shows the distal facingside 314 of the ball 180, with the terminals 310 a-d positioned over theslots 318 a-d. The pull wires themselves are not shown.

A tubular instrument port 320 is centrally positioned on the proximalsurface 316 of the ball 180. A retainer cap 322 covers the surface 316,such that the instrument port 320 extends through a central opening 324in the retainer cap. The sliding terminal plates 308 a-d are sandwichedbetween the surface 316 and the retainer cap 322. FIG. 22 shows the cap322 removed from the ball 180. The inner, distal facing, surface of thecap 322 includes a spiral rib 326 defining a spiral shaped slot 328.Each of the follower pins 312 a-d of the terminal plates 308 a-d aredisposed within the spiral slot 328.

A retaining ring 330 is engaged with the instrument port 320 andfunctions to hold the cap 322, terminal plates 308 a-d, and ball 180together such that the follower pins 312 a-d remain within the spiralslot 328. Cap is rotatable in clockwise and counterclockwise directionsrelative to the instrument port 320. Rotation of the cap will increaseor decrease the sensitivity of the gimbal system. More specifically, ifthe cap is rotated in a first direction, the spiral rib 326 will causethe pins 312 a-d to advance through the spiral slot towards the outercircumference of the cap, causing the terminal plates to slide radiallyoutwardly within slots, thereby increasing the sensitivity of the gimbalsystem. If the cap is rotated in a second direction, the pins willadvance through the spiral slot toward the center of the cap, causingthe terminal plates to slide radially inwardly within the slots so as toloosen the tension on the pullwires and to decrease the sensitivity ofthe gimbal, system. Markings 328 on the cap 322 and a correspondingpointer 330 instruct the user as to the level of sensitivity achievedwhen the cap is in one of the designated rotational positions relativeto the pointer 330.

In alternative configurations for adjusting gimbal sensitivity, the usermay have the option to set different sensitivity levels for differentones of the pull wires.

The system is preferably packed in a kit containing instructions for useinstructing the user to use the system in the manner disclosed herein.

FIG. 23 schematically illustrates use of the system of FIGS. 9 and 10 asused such as for a cholecystectomy procedure. According to such aprocedure, the access cannula 10 is placed transorally and moved intothe peritoneal cavity via a left anterior stomach wall puncture. Theaccess cannula 10 is anchored in a stomach incision as described above.The locking spine 102 is introduced into the peritoneal space and maderigid (via application of tension on the cables as described above) suchthat it is oriented towards the procedural site as shown. The liverretractor 35 a is used to lift and retract the liver superiorly awayfrom the gallbladder and the operational area of the instruments 32.Instruments 32 are advanced through the tool cannulas and used toperform the procedure. Tool cannulas 104 are deflected as needed tomanipulate the instruments. Whereas prior art laparoscopic proceduresinvolve formation of three surgical ports or incision X (tool port), Y(endoscope port), Z (tool port) to perform the cholecystectomyprocedure, use of the disclosed system allows the procedure to beperformed less invasively while allowing the surgeon to carry out theprocedure from the same familiar perspective from which s/he would haveperformed the laparoscopic procedure.

The embodiments disclosed above utilize locking spine devices in naturalorifice procedures to locate tools at or near the abdominal walls suchthat the tools may be manipulated in a way that is intuitive to thesurgeon given his/her experience with laparoscopic and/or open surgicaltechniques. Other systems that achieve this objective without the use ofa locking spine are also useable and fall within the scope of thisdisclosure. One example is shown in FIG. 24 in which a system 400 may beattached to the interior of the abdominal wall using a screw 402, t-bar404, inflatable balloon anchor, expandable braid, or similar deviceembedded in the facial layer of the stomach wall W. According to thisembodiment, the system 400 includes features that support a proceduralcannula 406 introduced into the peritoneal space via a natural orificeas described above. In the example shown, the procedural cannula 406 ispassed through or engaged with a guide ring 408 that helps to orient thedistal end 410 of the procedural cannula 406, and thus tools 412 passedthrough the procedural cannula 406, towards the treatment site. Asanother alternative embodiment, the system may use magnetism to support,retain and/or locate tools at the desired vantage point, such as nearthe inside of the abdominal wall. This embodiment might use cannulashaving magnetic features within the body, and an externalelectromagnetic outside the body. Alternatively, the embodiment mightemploy a steel/iron plate outside the body and magnetic cannulas thatare attracted to the steel/iron plate.

While certain embodiments have been described above, it should beunderstood that these embodiments are presented by way of example, andnot limitation. While these systems provide convenient embodiments forcarrying out this function, there are many other instruments or systemsvarying in form or detail that may alternatively be used within thescope of the present invention. This is especially true in light oftechnology and terms within the relevant art(s) that may be laterdeveloped. Moreover, the disclosed embodiments may be combined with oneanother in varying ways to produce additional embodiments.

Any and all patents, patent applications and printed publicationsreferred to above are incorporated by reference, including those reliedupon for purposes of priority.

1. A natural orifice surgical system comprising: an elongate supporthaving a flexible position and a rigid position, the supportproportioned for insertion into a body cavity through a natural orifice;an expandable frame supported by the elongate support in the rigidsystem, the frame expandable to an expanded position; and at least twotool cannulas coupled to the expandable frame, each tool cannula havinga lumen for receiving a tool for performing a procedure within the bodycavity, wherein the frame in the expanded position positions the lumensto give tools positioned in the cannulas access to a common operativesite.
 2. The system of claim 1, wherein the elongate support includes asegmented spine formed of a plurality of spine elements coupled by acable, the support moveable from the flexible to the rigid position uponapplication of tension to the cable.
 3. The system of claim 1, whereinthe elongate support includes a lumen, and wherein the tool cannulaextends through the lumen.
 4. The system of claim 1, wherein the toolcannula includes a plurality of pull wires coupled to a distal portionof the tool cannula, the distal portion deflectable in response toapplication of tension on at least one of the pull wires.
 5. The systemof claim 4, wherein the pull wires include proximal ends coupled to agimbal, the gimbal moveable in multiple directions to apply tension tothe pull wires.
 6. The system of claim 5, wherein the gimbal includes atool port having an opening, wherein the gimbal is moveable by movementof the tool port, and wherein the tool port is proported to receive adistal end of a tool as the distal end of the tool is advanced into thetool cannula.
 7. The system of claim 6, wherein the tool port ismoveable through movement of a handle of a tool positioned within thetool port.
 8. The system of claim 1, wherein the frame includes at leasttwo frame members, each frame member pivotally coupled to a toolcannula.
 9. The system of claim 1, further including an access cannulainsertable into a natural orifice and an anchor coupled to the accesscannula and expandable to retain the access cannula within an incisionformed within a wall of an internal body organ, the access cannulahaving a lumen, the elongate support, frame and tool cannulas insertablethrough the lumen of the access cannula when the frame is in a collapsedposition.
 10. The system of claim 4, wherein the system further includesa mount, and a pair of actuators on the mount, wherein the pullwires ofeach tool cannula are coupled to one of the actuators.
 11. The system ofclaim 10, wherein each actuator includes an instrument port, such that atool positioned in one of the tool cannulas extends through acorresponding one of the instruments ports, and wherein movement of ahandle of a tool within the instrument port actuates the pullwires. 12.The system of claim 10, wherein the mount is attachable to a surgicaltable.
 13. A method of performing a minimally invasive medicalprocedure, comprising the steps of: advancing an elongate support in aflexible state through a natural orifice and through an incision in abody organ into a body cavity; converting the elongate support from aflexible state to a rigid state; expanding a frame carried by theelongate support within the body cavity, the frame having a pair of toolcannulas coupled thereto; positioning medical tools within the toolcannulas and performing a procedure within the body cavity using themedical tools.
 14. The method of claim 13, further including the step ofdeflecting the distal portions of a tool cannula to alter the positionof the medical tool extending through the tool cannula into the bodycavity.
 15. The method of claim 14, wherein deflecting the tool cannulaincludes applying tension to a combination of pull wires coupled to adistal portion of the tool cannula.
 16. The method of claim 15, whereina proximal portion of the tool extends through a tool port, wherein thepull wires are coupled to the tool port, and wherein deflecting the toolcannula includes manipulating the proximal portion of the tool.
 17. Themethod of claim 16, wherein the method includes adjusting an amount bywhich tool cannula deflection is amplified relative to correspondingmovement of the tool.
 18. The method of claim 14, further including thestep of locking the tool cannula in a deflected position.
 19. The methodof claim 18, further including the step of, with the tool cannula in thedeflected position, withdrawing the tool from the tool cannula andinserting a second tool into the tool cannula.
 20. The method of claim13, wherein the natural orifice is selected from the group of naturalorifices including the mouth, the vagina and the rectum.
 21. The methodof claim 13, wherein in the rigid state the support member assumes acurvature selected to orient the tool cannulas towards a target sitewithin the body cavity.
 22. The method of claim 21, wherein the incisionis in the stomach, and wherein the curvature causes the support memberto extend in anterior and superior directions from the incision.
 23. Themethod of claim 21, wherein the incision is in the stomach, and whereinthe curvature positions the tools in the tool cannulas for access to agall bladder within the body cavity.
 24. The method of claim 13, whereinexpansion of the frame orients distal openings in the tool cannulastowards a target site within the body.